Engaging stakeholders for a holistic therapy in Alzheimer s disease

Transcription

1 Engaging stakeholders for a holistic therapy in Alzheimer s disease Brain Forum l Lausanne, May 26, 2016 l Prof. Andrea Pfeifer 2016 AC Immune. Not to be used or reproduced without permission.

2 Which company is bigger than..?????????????????? USD 818 billion USD 742 billion USD 568 billion USD 357 billion USD 280 billion 2

3 Worldwide estimated costs of Alzheimer s Today USD 818 billion In two years USD billion 3

4 Alzheimer s disease Early diagnosis and treatment are parallel goals Normal Prodromal AD Clinical Dementia Cognitive performance Prevent onset Reduce progression Reduce progression Improve symptoms Early Diagnosis Early Diagnosis Clinical Diagnosis Disease progression (years) Improve early diagnosis to guarantee early intervention when improved treatments are available 4

5 Alzheimer s disease Prevention, combination therapy and disease modifying therapies have major impact Cognitive performance Age/Time Prevention therapy Disease modifying combination therapy Disease modifying monotherapy Symptomatic combination treatment Symptomatic treatment Untreated 5

6 Clincial trials to stop Alzheimer s by 2025 Disease modifying Tau Amyloid SymptomaLc Drug candidate Mechanism Sponsor Phase Pa5ent popula5on Idalopirdine 5-HT6 antagonist Lundbeck Phase 3 Mild to moderate AD RVT HT6 antagonist Axovant Phase 3 Mild to moderate AD Dextromethorphan/ quinidine NMDA, sigma1, SERT, NET inhibilon Vs agitalon Avanir Phase 3 Mild to severe AD with agitalon secondary to AD Solanezumab anl-abeta mab Eli Lilly Phase 3 Mild and prodromal AD Crenezumab anl-abeta mab Roche/GNE Phase 3 Prodromal and mild AD Gantenerumab anl-abeta mab Roche Phase 3 Mild AD Aducanumab anl-abeta mab Biogen Phase 3 MCI due to AD and mild AD BAN2401 anl-abeta mab Eisai/Biogen Phase 2 MCI due to AD and mild AD CAD 106, CNP 520 anl-abeta vaccine, BACE inhibitor (individually vs placebo) NovarLs Phase 2 /3 CogniLvely unimpaired elderly ApoE 4 homozygotes MK8931 BACE inhibitor Merck Phase 2/3 Prodromal, mild to moderate AD AZD 3293 BACE inhibitor AZ/Lilly Phase 2/3 MCI due to AD and Mild AD TRx 0237 Tau aggregalon inhibitor TauRx Phase 3 Mild to Moderate AD ACI-35 ptau vaccine AC Immune/ Janssen Phase 1b 6 Mild AD AADvac 001 Tau vaccine Axon Neuroscience Phase 1b Mid to Moderate AD Azeliragon/TTP488 RAGE antagonist vtv Pharma Phase 3 Mild AD 6

7 Emerging strategies Combination therapy COMBINED SYMPTOMATIC AChEI plus + 5HT6 donepezil + RVT101 COMBINED DISEASE MODIFYING WITHIN TARGET AnL-Abeta mab + BACE inhibitor COMBINED DISEASE MODIFYING DIFFERENT TARGET Amyloid immunotherapy + Tau immunotherapy COMBINED DISEASE MODIFYING AND SYMPTOMATIC COMBINED DRUG TREATMENT/PREVENTION AND THERAPEUTIC NUTRITION 7

8 Regulatory agencies as a major player Designation of AD as a life threatening disease Enforcement of expanded access, accelerated approvals, including encouragement for treatment IND Adaptive licensing when possible Breakthrough Designation or PRIME scheme, when possible Validated Biomarker-based approvals Acceptance of one well-designed pivotal clinical trial Encourage early dialogue between agencies and industry Alzheimer s Help-desk) 8

9 Emerging strategies lifestyle and microbiome Finger study multidomain approach to prevention of cognitive decline Nutritional guidance Increasing evidence of significant role of microbiome on brain function Exercise Ref: Cryan et al., Nature Reviews Neuroscience 13, Cognitive training and cardiovascular Mgmt 25% higher improvement of global cognition Holistic approach for treatment and prevention of AD needs to include drugs and nutrition, lifestyle and microbiome Brain Forum l Lausanne, May 26, 2016 l Prof. Andrea Pfeifer 2016 AC Immune. Not to be used or reproduced without permission. 9

10 Key needs for therapy and prevention of AD Global AD health management Harmonized regulated environment Drugs Therapeutic Nutrition Diagnostic 10